1. Field of the Invention
The present invention relates to an implant for supporting the urethra of a man in order to treat urinary incontinence. The invention also relates to a surgical kit and to a method of treating urinary incontinence in a man, using such an implant.
2. Description of the Related Art
Urinary incontinence in men after prostatectomy constitutes an invalidating disorder that spoils quality of life even if the incontinence is moderate. The number of incontinent patients has increased over the last few years with the arrival of techniques for early detection of cancer of the prostate and with larger numbers of total prostatectomies being performed. Even though recent surgical techniques enable the sphincter to be preserved better, leaks of urine can occur in a non-negligible percentage of cases: these leaks of urine are associated with the surgical technique that causes the bottom portion of the prostate to be sectioned in the immediate vicinity of the sphincter, and they can also be made worse by specific elements associated with the patient, such as a short urethra, a sphincter that is weak or easily tired, etc.
For patients suffering from urinary incontinence in spite of sphincter re-education, the surgical treatment that has been commonly been used over the last few years consists in implanting an artificial sphincter. That operation limits incontinence very significantly, but suffers from major drawbacks: the patient needs to manipulate a pump on each urination, the implanted equipment is burdensome, and the repeat surgery rate is high.
A new surgical treatment technique has thus appeared recently, namely placing an implant that provides support under the urethra, which implant is generally in the form of a net or in a form of a plate. That kind of net needs to be firmly secured to anatomical structures of the patient in order to guarantee effective support of the urethra and thus correct incontinence. The plate is thus either suspended by threads rising up either side of the bladder, under or behind the pubis, and with terminal fastenings in the patient's abdominal wall, or else they are directly secured to screws in the patient's ischio-pubic bony branches. In the first configuration, the risk of perforating the bladder is real, and in the second the surgery is more complex and exposes the patient to a risk of ostitis. Either way, the presence of the implanted plate can lead to transient postoperative perineal discomfort, or indeed to permanent perineal pain. Furthermore, even if the success rate of the treatment is high in the short term, it tends to fall off significantly over time.
Simultaneously, equipment and methods for treating incontinence in women have recently been developed with success. In particular, EP-A-1 342 450 in the name of the present Applicant discloses a sub-urethral support strip that can be implanted in various ways including via a so-called “trans-obturator” approach, i.e. by passing the free end portions of the strip through the respective obturator foramens in a patient's ilium, thereby causing the urethra to be suspended on the longitudinally middle portion of the strip. The advantages of this trans-obturator implantation approach are real, since they run no risk of perforating the bladder and they do not require any fastening to bone, with only the free ends of the strip being secured in the patient's abdomen.